Astero StarFish

Unpacking the Potential of 6 Medtech Trends

Medtech Trends Potential“AI seems to be a thing. Everybody’s excited about ChatGPT.” Asking ChatGPT to list current medical device trends as preparation for our monthly content meeting has turned into our latest group blog.
Not surprisingly, the StarFish team identified the same trends proposed by ChatGPT- and more – with six of the most interesting trends making it into this blog.

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Ryan Field

Tolerancing Simulation for Medical Device Optical Systems

Tolerancing Medical Optical SystemsTolerancing is often an essential step in understanding the manufacturing/assembly requirements of an optical system designed for use in medical devices. The use of optical design software for tolerancing simulations is a valuable tool for identifying the specific manufacturing/alignment errors that can be allowed and their limits.
Zemax OpticStudio® is a popular optical design software that can facilitate the design of optical medical devices. The software includes a versatile tool for simulating the effects of tolerance errors on the performance of an optical system. In this blog, we give a basic overview of tolerancing in Zemax OpticStudio’s sequential mode.

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Tammy Lee

Revolutionizing Medical Imaging Devices with Optical Imaging

Optical Biomedical Imaging DevicesOptical imaging tools can enhance the crucial role of biomedical imaging in accurately identifying diseases and monitoring their progression.
Conventional medical imaging devices such as X-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, and positron emission tomography (PET) are commonly used in clinical settings (Figure 1). However, these imaging modalities are limited in their resolution, only being able to capture images at the millimeter scale or greater.

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Taimoor Khan

FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

FDA PCCP AI MLThe FDA recently (April, 2023) came out with a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The document provides guidance for developing a Predetermined Change Control Plan (PCCP) for managing changes to the device software functions.
The PCCP is a critical component of the regulatory approval process, as it ensures that changes to the AI/ML algorithms or models, that drive the device software functions are properly validated and verified before being implemented.

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Brian King

Incoherent-Light Hazard Classification for Medical Devices

Incoherent-Light Hazard ClassificationThere are numerous light-hazard classification standards that may pertain to your medical device: ISO 60601-2-57, IEC 62471, ANSI RP-27-20, ISO 15004-2, ANSI Z80.36, ISO 10936-2, ISO 10939, and so on…
In this blog post, I’ll examine certain commonalities and points of potential confusion of the “big 4” incoherent-light-source safety standards: IEC 62471 and ANSI RP-27-20 for “general biophotonic hazards”, and ISO 15004-2 and ANSI Z80.36 for hazards specific to ophthalmic devices and the patients to which they are applied.

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Muhammad Jamil

Computational Modeling and Simulation (CMS) is Changing Medical Device Development

Medical Device Computational Modeling and SimulationThe 21st century is going to bring massive changes to the medical device development sector and the role of computational modeling and simulation-based medical device development is expected to increase further.
In silico studies (physics based computational modeling and simulation) are already being used to virtually test medical devices.

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